FDA Law Blog

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

Annals of Family Medicine

NOVEMBER 20, 2024

Intervention/Instrument: Our presentation provides a comprehensive overview of our successes and opportunities. Conclusions: We map out strengths and opportunities for transformative leadership of the vision and strategic implementation of relationship science to build meaning and purpose in clinical practice, teaching, and research.

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Relationship Family Medicine DO Primary Care 130

Physician's Weekly

JUNE 13, 2025

This structured inquiry provides anesthesia professionals with the data needed to anticipate altered drug requirements and airway considerations, thereby enabling individualized perioperative plans. The CUBAT includes all these variables and provides example language for providers to use with patients,” the authors wrote.

Clinical Practice 52

Clinical Practice Healthcare Professional Healthcare Experience Screening 52

Physician's Weekly

JUNE 22, 2025

Investigators concluded that the finalized COS provided a foundation for standardizing outcome reporting in fecal incontinence research, with further work needed to define measurement tools and timing.

Healthcare Professional 52

Healthcare Professional Clinical Practice Clinic Healthcare 52

Medical Xpress

FEBRUARY 7, 2023

A new clinical practice guideline developed by the American Academy of Sleep Medicine provides recommendations for the management of REM sleep behavior disorder in adults.

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Provider Clinical Practice Management Clinic 79

Medical Xpress

APRIL 4, 2023

A subset of patients with alpha-gal allergy have gastrointestinal symptoms without skin changes or anaphylaxis, according to a clinical practice update published in the April issue of Clinical Gastroenterology and Hepatology.

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Provider Clinical Practice Clinic Patients 85

Physician's Weekly

JUNE 19, 2025

Ultrasound-guided catheter insertion and nonsilicone catheters are associated with a lower risk for complications with peripherally inserted central catheters (PICCs), according to results from a systematic review and meta-analysis published in Clinical Infectious Diseases.

Complication 52

Complication Clinical Practice Clinic Individual 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

Annals of Family Medicine

NOVEMBER 20, 2024

Physicians were active in clinical practice and several had expertise in either low-value care or patient-doctor communication. Results: Patients expected physicians to provide a rationale for ordering imaging or not, as they often considered imaging to be an indicator of high-quality care and desired imaging to relieve anxiety.

Clinical Practice 130

Clinical Practice Management Relationship Provider 130

Annals of Family Medicine

NOVEMBER 20, 2024

Background Researchers use card studies to obtain observational data about primary care provider (PCP) knowledge, attitudes, and behaviors on a variety of topics. Card studies have been influential in changing clinical practice, such as the reduction of antibiotics in patients with upper respiratory infections.

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PCP PCP Primary Care Clinical Practice 130

Barton Associates

MAY 8, 2025

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. Enter temporary medical staff, such as locum tenens providers. Many healthcare facilities in the U.S.

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Medical Staff Medical Patients Healthcare 52

Sound Physicians

NOVEMBER 19, 2024

It is, by design, built into the ways we educate, train, and support our clinical leadership. Fostering leadership potential While not every clinician aspires to be a leader , it ’ s crucial to provide avenues for those who do. Excellent leaders rise to the occasion when opportunities are open and available to them.

Hospital 52

Hospital Telemedicine Clinic Management 52

The Clinical Problem Solvers

JUNE 26, 2023

Episode Learning Objectives After listening to this episode, learners will be able to… Differentiate between stigma and bias in health care and the electronic health record using provided examples. Describe difficulties and examples of how to measure unconscious race bias in medical practice.

Electronics 52

Electronics Internal Medicine Patient-Centered Healthcare 52

The Clinical Problem Solvers

OCTOBER 18, 2022

Our guests remind us to think critically about our role in the carceral system and in imposing systems of control and punishment within clinical settings. Providing communities with the resources they need to survive, such as educational opportunities, jobs, and quality healthcare, will eliminate the need for incarceration.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

FDA Law Blog

JUNE 10, 2024

In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. 11-12 of the guidance for a list of these resources). Ask clarifying questions.

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Provider Electronics Clinical Practice Management 111

ABIM

MAY 7, 2025

Blueprints provide an outline of what content will appear on an assessment and the relative percentage of the assessment covered by each topic area. During this process, Item-Writers will often provide feedback and societies provide their own perspectives on behalf of their members.

Board-Certified Physicians 52

Board-Certified Physicians Board-Certified Provider Specialization 52

FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

Medical 111

Medical Clinic Patients IT 111

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance.

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Clinic Medical Provider Patients 52

FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

PEMBlog

AUGUST 30, 2023

As many as 40% of these children will receive a chest x-ray (CXR) during their ED visit despite clinical guidelines advising most of these tests are low value. Understanding root causes of CXR use in the ED clinical setting is key to mitigating overuse of this test.

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Asthma Electronics Utilities Clinical Practice 52

GeriPal

JANUARY 23, 2025

Join us as we dive deeper into these studies and discuss the implications for clinical practice and patient care. And there’s so much work on, you know, you’ve got to take these medicines, you got to prevent this treat, that there isn’t that same sort of clinical momentum towards deprescribing. Alex 15:36 Yeah.

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Specialization IT Patient-Centered Medical 119

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective.

Screening 119

Screening Primary Care Patient-Centered IT 119

ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

PEMBlog

SEPTEMBER 27, 2023

The diagnosis of a virus illness is generally made clinically with a history and clinical exam and does not require confirmatory testing. A negative test can also provide false reassurance. The clinical utility of respiratory viral testing in hospitalized children: a meta-analysis. for bronchiolitis and 1.5% JAMA Pediatr.

Patients 52

Patients Illness Hospital Management 52

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Patient-Centered Patients Clinic 120

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Primary care providers (PCPs) frequently treat children and adolescents with obesity. In 2023, the American Academy of Pediatrics released new clinical practice guidelines (CPG) for the evaluation and treatment of pediatric obesity.

Clinical Practice 130

Clinical Practice Clinic Education Primary Care 130

FDA Law Blog

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider. Proposed practitioner recordkeeping obligations.

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Telemedicine Telecommunication Telehealth Medical 59

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. And he is also a clinical audiologist, which is going to be key for this podcast. I’m guessing not. Transcript.

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IT Screening Hospital Clinic 102

GeriPal

JANUARY 12, 2023

Not every hospital or every health system is the same physically or financial incentives or which clinical programs exist and patient demographics. And even though ACE students have been shown to have great clinical outcomes like decreased hospital harms, yes, health system leaders care about that.

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Hospital Patient-Centered IT Nurse Practitioner 100

PEMBlog

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Understanding dyspepsia and its clinical presentation. Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

Physician's Weekly

JUNE 13, 2025

Mining Data The researchers mined electronic medical record data from the United Kingdom’s Clinical Practice Research Datalink. The potentially long latency period might provide an opportunity to identify individuals who would benefit from earlier LC detection,” researchers wrote.

Diagnose 105

Diagnose Screening Clinical Practice Electronics 105

FDA Law Blog

SEPTEMBER 10, 2023

Interventional studies are generally clinical investigations under the regulations and thus require an IND under 21 C.F.R. § Even though an IND is not required, this guidance is intended to provide recommendations for sponsors to follow for using RWE from such studies for regulatory decision-making.

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Provider Patient-Centered Clinic Patients 108

GeriPal

JUNE 12, 2025

Eric 00:42 So on this podcast, we’re gonna be talking about what every healthcare provider should know about radiation oncology. I’m sort of seeing them in clinic for consideration of palliative radiation, they have a lot going on. Evie, welcome to GeriPal. Evie 00:41 Thank you. Do you have the song request for Alex?

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Patient-Centered Referral Patients IT 102

FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

Clinic 64

Clinic Supply Chain Clinical Practice Patient-Centered 64

ABIM

JUNE 24, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research. ASH has engaged in lobbying efforts in Washington, D.C.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

FDA Law Blog

MARCH 17, 2022

Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. Proposed 2022 CDC Practice Guideline, 7,839. CDC Clinical Practice Guideline, 10. 7,838 (Feb. 10, 2022); Dowell, Deborah, MD.,

Patient-Centered 75

Patient-Centered Clinical Practice Patients Individual 75

FDA Law Blog

MARCH 6, 2025

population due to differences in demographics, practice of medicine, or standard of care. inpatient hospital, out-patient clinic), date range for the data, and location of the data collection sites (e.g., sampled from completely different clinical sites), and any data cleaning or processing performed on the training or tuning data.

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Manufacturing Management Clinical Practice Clinic 105